To assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hot flush score: percentage reduction in hot flush score and the number of
subjects reaching a flush score reduction >50%.
Hot Flush score = mean daily flush frequency x flush severity
(flush severity = mean severity score of every flush on a 1-4 scale)
Secondary outcome
Quality of life, measured with 5 questionnaires:
a. Hot Flash-Related Daily Interference Scale (HFRDIS)
b. Epworth Sleepiness Scale (ESS)
c. PSQI (Pittsburgh Sleep Quality Index)
d. MENQOL (Menopause-Specific Quality of Life)
e. CES-D (Center for Epidemiologic Studies Depression Scale)
Background summary
Hot flushes are the most common symptom of menopause for which postmenopausal
(PMP) women seek medical help. In 20% of PMP women hot flushes can persist for
up to 15 years. Some women will have hot flushes several times a week, whereas
others experience symptoms every hour or more. Flushing, in addition to
discomforting effects in daytime, may also disrupt sleep and thereby cause
chronic fatigue, irritability and depression. About 20% of PMP women find the
symptoms intolerable.
A possible treatment for hot flushes is stellate-ganglion block (SGB), used as
a means to interrupt parts of the sympathetic nervous system involved in
temperature regulation. Stellate-ganglion blocks have been performed safely for
more than 60 years in patients for various pain conditions. Several studies
have demonstated promising results in women with severe flushes.
Study objective
To assess the short-term efficacy of stellate ganglion block on hot flush
reduction versus sham procedure
Study design
-Single center: Rijnstate Hospital, Arnhem, The Netherlands
-Setting: outpatient setting
-Screening: Recording of flushes by diary for a period of 7 days. Minimum of 10
flushes per day or a hot flush score of 15 or more is required
-After inclusion:
-Week 0:
Start recording of flushes by diary 24 hrs/day
Questionnaires: HFRDIS, PSQI, ESS, MENQOL, CES-D
-Week 1:
Day 1: Randomization. SGB/sham procedure will be performed by Dr Kallewaard,
anesthesiologist
- Week2; week 4: week 8; week 12; week 26 = beginning of the week
questionnaires: HFRDIS, PSQI, ESS, MENQOL, CES-D
- Week2; week 4: week 8; week 12; week 26 = all week recording of hot flushes
frequency and severity
- week 4: taking bloodsample to check hormones related to hot flushes and
menopause
Intervention
stellate ganglion block versus sham-procedure
Study burden and risks
Burden mainly consists of reporting in the diary. The risks are very small and
the procedure minimally invasive.
Wagnerlaan 55
Arnhem 6815 AD
NL
Wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
female
age 30-70
mean daily flush frequency >9
hot flush score >14
absence of reasons for flushing other than post-menopausal (spontaneous or medical induced)
postmenopausal > 1 year in healthy women (e.g. spontaneous)
Exclusion criteria
- Use of medication that affects flushing:
estrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlaflaxine, gabapentin, LHRH receptor antagonist
- Still receiving chemotherapy of radiotherapy
- allergy for contrast dye or local anesthetics of amide type
- active concurrent somatic disease
- active concurrent psychiatric disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2016-001180-36-NL |
ClinicalTrials.gov | NCT02295163 |
CCMO | NL54465.091.16 |